C2 Therapeutics said today it won FDA 510(k) clearances for its Coldplay cryoballoon full ablation system and swipe ablation system.
The Redwood City, Calif.-based company’s devices are designed to treat precursors to esophageal cancer known as Barrett’s Esophagus.
“The clearance of Coldplay Cryoballoon Full and Swipe Systems is an important milestone in broadening the company’s portfolio. The full and swipe ablation systems will be critical in allowing physicians to ablate larger areas of tissue in endoscopic applications,” CEO Peter Garcia-Meza said in a press release.
Barrett’s Esophagus develops due to injuries from gastroesophageal reflux disease which wares down the esophageal lining, leaving previously healthy cells replaced by abnormal cells that are more vulnerable to cancer, C2 Therapeutics said.
“The U.S. regulatory clearance of the promising Coldplay Full and Swipe Ablation Systems is a major leap forward in the care of patients with Barrett’s Esophagus at risk for development of esophageal cancer. These technologies provide endoscopists with more options to eliminate Barrett’s Esophagus and improve patient outcomes,” Dr. George Triadafilopoulos of Stanford University said in prepared remarks.
Last October, C2 Therapeutics raised $11.6 million in equity funding, according to a regulatory filing.