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The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.

The C2 CryoBalloon™ EndoGrip is an accessory product that is used in conjunction with therapeutic endoscopes and therapeutic catheters (the C2 CryoBalloon™ Catheter of the C2 CryoBalloon™ Ablation System). The C2 CryoBalloon™ EndoGrip consists of a Clip Base, Rubber Grip, and Compression Spring. This is supplied non-sterile. The EndoGrip is used to anchor catheters in place relative to the scope. In a clinical application, once the endoscope is delivered into the gastric anatomy and positioned at its desired location the physician may insert the catheter through the endoscope. When the catheter is located properly in its axial position, the EndoGrip is positioned against the biopsy valve by depressing the clip mechanism and sitting the catheter on the rubber grips. The revised design allows for placing the EndoGrip after the CryoBalloon catheter is in place in the scope and for repositioning without having to completely withdraw and reinsert the catheter. The C2 CryoBalloon™ EndoGrip is designed for one-time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID) or a C2 Sidecar (FG -1011), which serves as an external channel for therapeutic devices when a therapeutic endoscope is unavailable for use.

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.

The subject and marketed predicate device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use). The subject and marketed predicate 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 pre-inflated balloon, and the treatment site is selected is by adjusting the endoscope and Catheter The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.