Study: NCT00848237

Adverse event: Pain, Nausea, vomitting, fullness, abdominal discomfort
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 5521 at risk

Adverse event: Dysphagia and/or Odynophagia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 5521 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Dysphagia/Upper GI Bleed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Esophageal spasms
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Esophagitis and/or Ulceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 5521 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 5521 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Melaena
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 5521 at risk

Adverse event: Mucosal Tear / Laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Stricture and/or dysphagia requiring dilatation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 5521 at risk

Adverse event: Upper GI Bleeding
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 5521 at risk

Adverse event: Catheter interaction with existing sutures
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Dysphagia and/or Odynophagia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 5521 at risk

Adverse event: Esophageal spasms
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Esophagitis and/or Ulceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 5521 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Mallory-weiss tear
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Mucosal Tear / Laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 5521 at risk

Adverse event: Mucosal trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Oxygen desaturation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Pain, Nausea, vomitting, fullness, abdominal discomfort
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 5521 at risk

Adverse event: Prior Stricture worsen by RFA
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Sizing Balloon did not work
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5521 at risk

Adverse event: Stricture - no dilatation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 5521 at risk

Adverse event: Stricture and/or dysphagia requiring dilatation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 37 affected / 5521 at risk

Adverse event: Stricture requiring dilatation- History EMR or Stricture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 5521 at risk

Adverse event: Upper GI Bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 5521 at risk