FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Positive Data Unveiled From Two Studies of Coldplay CryoBalloon

Nov. 11, 2015
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C2 Therapeutics has announced data from two studies it says demonstrate the safety and efficacy of its Coldplay CryoBalloon Focal Ablation System.

The first study, which included 26 patients, evaluated the efficacy of the system, designed to eradicate Barrett’s esophagus. The company reported complete eradication of BE islands in 35 of the 37 treated areas. No adverse events occurred during ablation.

No strictures were detected in a follow-up endoscopy with biopsy performed in 24 of 26 patients. Seven patients experienced mild pain directly after the procedure, while two suffered from mild pain during swallowing at two days following the procedure.

A second study evaluated the feasibility of endoscopic eradication of early esophageal squamous cell neoplasia with the system. — Michael Cipriano