Catheter, gastrointestinal balloon

Intended purpose

Indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to Barrett's Esophogusand Esophageal and Squamous Cell Neoplasia, defined as moderate grade intra-epithelial neoplasia, high-grade intraepithelial neoplasia and/or early squamous cell carcinoma of the esophagus limited to the lamina propria.