Device Recall C2 CryoBalloon Ablation System

All lots distributed between June 23, 2016 and December 20, 2016: UPDATE - expanded to include product distributed from February 1 2016 through February 8, 2017. All numbers below have been updated. Lot numbers: Expiry dates 01122016-02 12-Jul-16; 06242016-01 1-Jan-2017; 11282016-03 2-Jun-2017; 01042016-03 14-Jul-16; 06292016-02 6-Jan-2017; 09202016-01 21-Mar-2017; 07062016-01 8-Jan-2017; 09222016-01 23-Mar-2017; 01252016-02 02-Aug-16; 07082016-02 13-Jan 2017; 09232016-01 28-Mar-2017; 01282016-01 01-Aug-16; 07082016-03 14-Jan-2017; 09232016-02 27-Mar-2017; 01292016-01 02-Aug-16; 07152016-01 21-Jan-2017; 09292016-01 4-Apr-2017; 02022016-03 09-Aug-16; 07152016-02 20-Jan-2017; 09302016-03 4-Apr-2017; 02082016-01 09-Aug-16; 07212016-01 25-Jan-2017; 10052016-02 19-Apr-2017; 02092016-02 11-Aug-16; 07252016-01 28-Jan-2017; 10142016-01 18-Apr-2017; 02112016-02 17-Aug-16; 07262016-01 9-Feb-2017; 10192016-01 24-Apr-2017; 02172016-02 25-Aug-16; 07282016-02 2-Feb-2017; 10212016-01 25-Apr-2017; 02222016-01 26-Aug-16; 08022016-01 17-Feb-2017; 10242016-01 26-Apr-2017; 03012016-01 04-Sep-16; 08032016-02 5-Feb-2017; 10262016-02 1-May-2017; 03072016-01 10-Sep-16; 08112016-01 16-Feb-2017; 10282016-02 8-May-2017; 03102016-02 15-Sep-16; 08232016-01 26-Feb-2017; 11022016-01 9-May-2017; 03152016-03 21-Sep-16; 08262016-01 2-Mar-2017; 11042016-01 10-May-2017; 03282016-02 29-Sep-16; 09022016-01 8-Mar-2017; 11092016-01 15-May-2017; 03292016-01 31-Sep-16; 09092016-01 14-Mar-2017; 11142016-02 16-May-2017; 09122016-02; 15-Mar-2017;  11152016-02 18-May-2017; 04012016-01 06-Oct-16; 09192016-01 19-Mar-2017; 11162016-01 21-May-2017; 09192016-02 21-Mar-2017; 11282016-02 30-May-2017; 04062016-01 12-Oct-16; 11302016-02 02-Jun-17; 12052016-01 08-Jun-17; 04112016-04 14-Oct-16; 12052016-03 06-Jun-17; 04142016-01 20-Oct-16; 12072016-01 09-Jun-17; 04202016-02 21-Oct-16; 12092016-01 13-Jun-17; 05022016-02 05-Nov-16; 12132016-01 19-Jun-17; 05092016-01 11-Nov-16; 12152016-02 20-Jun-17; 05162016-02 18-Nov-16; 01042017-01 04-Jul-17; 05232016-01 25-Nov-16; 01052017-03 19-Jul-17; 05272016-01 02-Dec-16; 01052017-04 19-Jul-17; 06022016-02 09-Dec-16; 01092017-01 12-Jul-17; 06102016-01 14-Dec-16; 01102017-01 18-Jul-17; 06152016-01 21-Dec-16; 01132017-01 18-Jul-17; 06172016-01 23-Dec-16; 01132017-03 17-Jul-17; 07282016-02 02-Feb-17.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China.

C2 CryoBalloon Ablation System - Controller Cap. || C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device || The affected product is the Controller Cap component only, which is provided to || the customer already assembled onto the Controller. || Model number: FG-1012 || Product Usage: || The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.