Description of Event or Problem · 1
THIS IS A REPORT OF AN ADVERSE EVENT OCCURRING IN A PT ENROLLED IN THE US BARRETT'S RFA REGISTRY. THE PT IS A MALE WITH HIGH-GRADE DYSPLASIA IN A BARRETT'S ESOPHAGUS. THE PT HAD AN ESOPHAGECTOMY IN 1999. NO DATA ON EXTENT OF ESOPHAGECTOMY AVAILABLE IN NOTES, BUT THEN FOUND TO HAVE RESIDUAL BARRETT'S ESOPHAGUS WITH HIGH-GRADE DYSPLASIA (6 CM IN LENGTH). INITIAL ABLATION WAS PERFORMED FOCALLY EVERY TWO MONTHS FOR THREE SESSIONS. APPROX 2 WEEKS AFTER THE LAST SESSION, THE PT REPORTED DIFFICULTY SWALLOWING. ENDOSCOPY REVEALED SOME ULCERATION CONSISTENT WITH A RECENT ABLATION. A MILD STRICTURE WAS IDENTIFIED HIGH IN THE REMNANT ESOPHAGUS 24 CM FROM INCISORS. CYTOLOGY SHOWED CANDIDA ESOPHAGITIS. NO DILATION PERFORMED AT THAT TIME. PT WAS PROVIDED WITH PROTON PUMP INHIBITORS AND ANTI-FUNGAL THERAPY. APPROX 2 WEEKS LATER, THE ESOPHAGUS WAS HEALED AND THE STRICTURE DILATED. DILATION WAS REPEATED 1 MONTH LATER. THE PHYSICIAN REPORTS THAT THE STRICTURE HAS IMPROVED BUT HAS NOT YET RESOLVED COMPLETELY. PER THE PHYSICIAN REPORT, THE ADVERSE EVENT SEVERITY WAS MODERATE, THE RELATIONSHIP TO THE DEVICE PROCEDURE WAS DEFINITE, AND THERE WAS NO DEVICE MALFUNCTION.